UNKNOWN
Received Apr 9, 2012 · Event occurred Sep 9, 2011
Report 2124215-2012-04851 · MDR key 2523992
Device
Product problems
- Failure to Capture
- Fracture
- High impedance
- Device Sensing Problem
Patient
80 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CHECK, THIS LEFT VENTRICULAR (LV) LEAD SHOWED FREQUENT SENSED EVENTS CAUSED BY NOISE, AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. IT WAS UNCLEAR WHETHER THIS LEAD HAD FRACTURED. THE PATIENT'S LV CAPTURE THRESHOLD WAS FOUND TO HAVE INCREASED TO A VALUE THAT WAS HIGHER THAN THE PROGRAMMED OUTPUT, BUT THE PATIENT WAS ASYMPTOMATIC TO LOSS OF LV CAPTURE. THE PATIENT HAD INTACT 1:1 AV NODAL CONDUCTION. THE CLINICIAN DECIDED TO PROGRAM THIS LV LEAD OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CHECK, THIS LEFT VENTRICULAR (LV) LEAD SHOWED FREQUENT SENSED EVENTS CAUSED BY NOISE, AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. IT WAS UNCLEAR WHETHER THIS LEAD HAD FRACTURED. THE PATIENT'S LV CAPTURE THRESHOLD WAS FOUND TO HAVE INCREASED TO A VALUE THAT WAS HIGHER THAN THE PROGRAMMED OUTPUT, BUT THE PATIENT WAS ASYMPTOMATIC TO LOSS OF LV CAPTURE. THE PATIENT HAD INTACT 1:1 AV NODAL CONDUCTION. THE CLINICIAN DECIDED TO PROGRAM THIS LV LEAD OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.